A Randomized, Double-Blind, Placebo-Controlled, Phase 1 / 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Single Ascending Doses of TRCN-1023 Administered by Intrathecal Injections to Adult People Living with Amyotrophic Lateral Sclerosis

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523111-11-00

Enrollment

Registered

2026-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis

Brief summary

Frequency of adverse events over [CCI] weeks

Detailed description

Plasma and CSF TRCN-1023 concentrations, Plasma PK parameters including, but not limited to, time of maximum observed concentration (Tmax), maximum observed concentration (Cmax), and area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUClast)

Interventions

DRUGTRCN-1023

DRUGartificial cerebral spinal fluid

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events over [CCI] weeks	—

Secondary

Measure	Time frame
Plasma and CSF TRCN-1023 concentrations, Plasma PK parameters including, but not limited to, time of maximum observed concentration (Tmax), maximum observed concentration (Cmax), and area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUClast)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 23, 2026